High Definition Neuromuscular Stimulation in Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in Voluntary Movement
研究概览
简要总结
The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants.
详细描述
Spinal cord injury (SCI) is an insult to the spinal cord resulting in a change, either temporary or permanent, in its normal motor, sensory, and/or autonomic function. It is estimated that the annual incidence of spinal cord injury (SCI), not including those who die at the scene of the accident, is approximately 40 cases per million population in the U. S. or approximately 12,000 new cases each year.
The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants. This study will plan to enroll up to 15 subjects who have been diagnosed with tetraplegia. The total duration of the study is expected to be about 18 months, and each participant is expected to be on the study for about 6 months.
The study design will consist of the following two (2) phases listed below. I. Baseline assessment and calibration (approximately 1 month) II. Testing motions: pre-sequenced and EEG-triggered motions; further calibration as needed (approximately 5 months)
Phase I - Baseline
- Medical history review
- Physical and neurological exam
- EMG
- Fit and calibrate external stimulator: The Battelle Neuromuscular Stimulator will be setup and calibrated to evoke wrist and hand/finger movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 21 years or older.
- •Must be tetraplegic (C4-6 ASIA A)
- •12 months post injury and neurologically stable
- •Participant is willing to comply with all follow-up evaluations at the specified times.
- •Participant is able to provide informed consent prior to enrollment in the study.
- •The participant is fluent in English.
排除标准
- •No active wound healing or skin breakdown issues.
- •No history of poorly controlled autonomic dysreflexia.
- •Other implantable devices such as heart/brain pacemakers
- •Subjects who rely on ventilators
结局指标
主要结局
Change in Voluntary Movement
时间窗: through study completion, up to 60 months
consistent and repetitive voluntary movement in the targeted muscle groups as assessed by investigator(s)- no formal scale is used. The participant(s) started out with paralysis due to spinal cord injury, so any active voluntary movement consists of a qualitative change in movement.
次要结局
- Change in Functional Movement(through study completion, up to 60 months)
研究者
Marcia Bockbrader
Assistant Professor- Physical Medicine & Rehabilitation
Ohio State University